FDA + Healthcare Regulatory Associate Attorney

Job Description

Job Description

FDA + Healthcare Regulatory Associate Attorney

Location: Washington, DC

Direct Counsel is seeking an FDA + Healthcare Regulatory Associate to join the FDA and Healthcare Regulatory & Compliance Practice Group of a premier global law firm in Washington, DC. This is an exceptional opportunity for an associate with FDA regulatory experience to work with innovative clients across the food, beverage, dietary supplement, pharmaceutical, biotechnology, medical device, cosmetic, and healthcare technology industries.

The ideal candidate will have experience advising FDA- and USDA-regulated companies on complex regulatory, compliance, and product lifecycle matters, with a strong interest in counseling fast-growing brands and emerging companies in the consumer products and life sciences sectors.

Responsibilities

• Advise clients on FDA and USDA regulatory and compliance matters across the product lifecycle
• Counsel clients in the:
  • Food and beverage industry
  • Dietary supplement sector
  • Pharmaceutical and biotechnology industries
  • Medical device and healthcare technology spaces
  • Cosmetic and consumer products industries
• Provide guidance regarding:
  • Product development and commercialization strategies
  • Labeling, advertising, and promotional compliance
  • Safety and regulatory compliance issues
  • Adverse event reporting
  • Product recalls
  • FDA and USDA inspections
  • Remediation of inspection findings
• Draft regulatory analyses, client advisories, compliance policies, and agency submissions
• Work directly with clients to develop practical and business-oriented regulatory strategies
• Collaborate across practice groups on sophisticated regulatory, enforcement, and transactional matters

Qualifications

• J.D. from an accredited law school with strong academic credentials
• 3–5 years of FDA regulatory experience at a leading law firm and/or FDA or USDA
• Experience advising FDA- and USDA-regulated clients required
• Experience representing food, beverage, dietary supplement, pharmaceutical, cosmetic, and/or medical device clients preferred
• Strong interest or experience counseling fast-moving consumer brands and retailers
• Excellent analytical, drafting, and communication skills
• Ability to independently manage matters and maintain direct client relationships
• Entrepreneurial mindset with strong business judgment and collaborative skills
• Admission to the applicable state bar or eligibility to waive in

Compensation & Benefits

• Salary range: $260,000 – $365,000, depending on experience and qualifications
• Competitive discretionary bonus opportunities
• Comprehensive medical, dental, vision, life, and disability insurance
• Industry-leading parental leave and family support benefits
• 401(k) and Roth 401(k) retirement plans
• Wellness and mental health resources, including employee assistance and wellness programs
• Flexible time away and reduced schedule arrangements
• Paid bar registration and professional association fees
• Robust mentorship, sponsorship, and career development programs
• Significant pro bono opportunities and charitable matching initiatives

This is an outstanding opportunity for an FDA regulatory associate seeking sophisticated advisory work, direct client engagement, and long-term career growth within a collaborative and nationally recognized life sciences and healthcare regulatory practice.